In light of the new guidance from the Food and Drug Administration (FDA) and numerous high profile court cases, it is necessary for companies to continue to stay current with new regulatory requirements in regards to field-based team interactions with prescribers and off-label information. CBI’s 14th Annual Forum on Off-Label Guidelines, October 11-12, 2012 at the Doubletree Hotel Center City in Philadelphia, PA, convenes the industry’s leading pharmaceutical, biotech and medical device executives to discuss regulatory guidance, field force oversight, promotional review and more.
Industry must continue to revaluate and update their internal standard operating procedures (SOPs) to ensure all medical and promotional information complies with current off-label regulations. This interactive forum provides a platform for industry peers to review and discuss best practices regarding compliance and legal oversight as well as an opportunity to discuss industry benchmarks, activities and practical guidelines for off- label information.
- Discuss implications of the FDA Guidance released in December of 2011
- Understand the current regulatory environment for off-label information
- Learn from industry experts how companies are monitoring interactions between field force teams and prescribers
- Define what constitutes as solicited vs. unsolicited information
- Review influential court cases as well as recent OPDP warning letters regarding off-label allegations
The two day workshop will include a number of important panels and esteemed speakers who will address the trends and challenges companies face in the current regulatory environment with respect to off-label promotion. Below is a summary of some of the panels.
Understand the Current Environment for Off-Label and Misbranding Compliance
The current environment for off-label information continues to evolve as enforcement focus moves away from obvious off-label promotion outside of an approved therapeutic indication, to misbranding by overstating efficacy or minimization of risk information. While biopharmaceutical and device companies continue to adjust their internal compliance activities to prevent “the same old violations”, many questions and clarifications remain unanswered on what is compliant practice versus what is considered misbranding or off-label promotion. During this session, hear from a former government prosecutor who now represents whistleblowers in misbranding and off-label promotion qui tam cases.
- Hear what whistleblowers are saying about their company’s conduct
- Review the current trends in the type off-label allegations cited by OPDP
- Understand the evolving nature of misbranding off-label allegations
- Discuss the future of off-label in the face of the new FDA Guidance and Federal Review Notice
- An Update on Recent OPDP Warning Letters, Notice of Violation (NOV) and FDA’s Bad Ad Program
In 2012, FDA’s Office of Prescription Drug Promotion (OPDP) has asked for “voluntary” compliance to prevent common violations including omission and minimization of risk information, misleading claims of efficacy, promotion of unapproved uses and misleading superiority claims. While this request is certainly a heads up to the industry, and promotional activities by industry appear to be improving, there are still activities and materials which are of concern to OPDP. Surveillance activities have been augmented by the introduction of the Bad Ad program and the reporting of in-person promotional violations may be increasing. In this session, review OPDP Warning Letters and NOVs to better understand what language and information constitute as off-label information.
Off-Label Legislation — Identify and Address Risk for Executives and Individuals
The government has begun aggressively assessing personal liability against individuals within corporations, in addition to levying civil and criminal assessments against corporations for off-label promotion violations. While some of the governmental actions have been against individuals directly responsible for the decision-makers, in other instances, the government has opted to proceed against individuals not directly responsible, rather, through the individuals’ standing within the organization. Under the so-called Park Doctrine, or Responsible Corporate Officer Doctrine, corporate officers are held responsible based solely upon his or her position and responsibility, and without evidence of specific wrong-doing. With an increase in enforcement actions against individuals, companies are examining what steps they can take to protect their employees and management team. This session examines what actions the government has taken against individuals, describes the legal theories government is utilizing and reviews precautions that companies can take to prevent individual liability, improve compliance programs and revise policies to prevent violations.
- Review recent enforcement actions against individuals and the underlying alleged activity
- Learn which actions have been successful and which have failed
- Review recent enforcement actions against individuals and the underlying alleged activity
- Learn which actions have been successful and which have failed
- Understand the legal theories the government is employing, including the origins of the Park Doctrine and how it is being applied
- Acquire key takeaways to improve internal compliance activities
Federal Prosecutors’ Discussion: Recent Trends in State and Federal Enforcement — Evaluate Recent Complaints, Investigations and Settlements with Federal Prosecutors
In addition to the federal government False Claim Act, several states have created False Claim Act statues with qui tam provisions. Off-label promotion continues to be the major factor in the majority of settlements — whether it be a misbranding issue, overstating of benefits or another violation. Previous cases have shown that adhering to FDA guidelines is not enough. To ensure compliance, pharma must be aware of both FDA and individual state restrictions. During this discussion, hear directly from the prosecutors on their areas of focus, insight into current trends in off-label cases and recommendations to lessen the risk of off-label promotion.
- Hear recommendation from the government on how to monitor and prevent off-label promotion
- Identify top priorities for enforcement
- Discuss and evaluate False Claim Act Statues across federal government and individual states
- Understand the Benefits of Proper Off-Label Compliance Training and Monitoring Field-Based Sales Operations
Many companies see communication and interactions between field-based sales teams and prescribers as a major concern for off-label promotion and risk to the organization. The FDA has tried to create more concrete restrictions with the new guidance, but most in the industry remain unclear on what is legal and illegal information exchange. And with the rise of the social media platform, communications are now far reaching, with the potential for unintended consequences.
In this changing environment, both small and large companies alike must monitor field-based sales and company-wide communications to ensure that they are adhering to FDA, state and DOJ guidelines. It is through a corporate training and monitoring program where compliance and legal teams can ensure that all communications remain compliant. Yet the extent of monitoring, particularly with respect to social media, is a concern and challenge. In this session, explore common risk areas for compliance in field-based operations as well as the importance of training, tracking and monitoring these activities to illustrate and actively obey compliance efforts.
- Learn how to effectively track communications between field-based teams and physicians
- Discover the positive impact of a concrete, internal set of compliance regulations
- Establish ways to prevent the relay of off-label information from sales to prescribers
- Learn tips for creation of an internal social media policy that addresses appropriate and inappropriate communication
- Uncover the benefits of cross-company training on what is and is not off-label communication
- Essential Elements of Compliant Scientific Exchange under New FDA Guidance
In its Federal Register Notice, the FDA notes that it was particularly interested in reviewing the public’s response to a group of thirteen questions based on the legality of scientific exchange. As a result, the distinction between scientific exchange and promotion for industry remains unclear under the new guidance. This uncertainty creates a barrier as the pharmaceutical and medical device industries encourage scientific exchange to ensure patients receive the most appropriate treatment. During this session, explore the elements that allow for compliant scientific exchange to ensure that patients continue to benefit from therapy innovation and appropriate uses of currently available therapies in this informative session.
- Discuss elements of appropriate and inappropriate scientific exchange
- Relate these elements to the FDA’s recent request for public response answering the thirteen questions related to scientific exchange
- Define the distinctions between scientific exchange and promotion
- Understand the difference between communications concerning the use of unapproved products versus new uses of approved products
- The Importance of Monitoring Target Lists and Compensation Plans for Field-Based Sales Operations — Lessons Learned from Recent Litigation
Recent litigation trends indicate that the government is increasing its focus on sales target lists, compensation plans and sales goals related to off-label compliance. Industry guidance recommends that companies examine whether the current company policies, procedures and practices encourage improper promotional practices. In this session, review recent government settlements, understand what the government sees as red flags and discuss better industry practices.
- Analyze recent industry guidance regarding target lists, sales goals and compensation plans
- Discuss red flags in compensation plans, target lists and sales goals that should be monitored
- Discuss better industry practices to mitigate risk of off-label promotion related to target lists, sales goals and compensation plans
- Effectively Manage and Improve Compliant Interaction Between Field-Based Sales and MSLs
Many companies see communication and interaction between field-based sales teams and Medical Science Liaisons as a major risk to the organization. In response to government claims that MSL teams have been misused to promote off-label, many companies have put a firewall between their medical affairs and commercial operations in an attempt to demonstrate a clear independence of MSL teams from commercial influence. By doing this, companies have successfully lowered their risk; however, these critical functions now rarely communicate, creating a barrier for appropriate and valuable knowledge exchange and effectively blocking a successful transition of products from development to commercialization.
There is significant benefit in finding a compliant method of communication between sales and MSLs but requires ongoing effective management and comprehensive training to mitigate potential risk. Such a dynamic model takes time and effort, but if done correctly and compliantly can result in great gain to the organization. In this session, learn about the benefits of effectively managing communication between field-based sales and MSLs as they carry out their respective roles in interactions with prescribers.
- Discuss appropriate distinctions between promotion and scientific exchange to ensure understanding of a compliant internal and external communication processes
- Discuss the benefits and potential pitfalls of joint training sessions with MSLs and sales representatives that address the purpose of each function, how to communicate appropriately in the field and how to respond compliantly to unsolicited requests for off-label information
- Learn how to manage communication between MSL teams and their commercial colleagues to minimize risk and maximize value to the organization
- Case Study: The Changing Role of MSLs in the Current Compliance Environment — What it Means for Medical Affairs Departments
As a result of new FDA guidance, company reorganization and shrinking budgets; new questions regarding how to communicate on- and off-label information continues to be discussed in detail for MSL departments. New questions about what communications, both on-label and off-label, fall under the umbrella of complaint MSL interactions continue to arise. Seven pharmaceutical companies recently filed a Citizen Petition asking for information on appropriate communication on how truthful, non-misleading information that is not included in product labeling can be communicated. As MSLs are usually at the forefront of this type of communication and respond to unsolicited requests; companies must define the proper interface between field sales and MSLs within an organization. During this session, learn about the changing environment of MSL departments and what constitutes as compliant interactions according to the federal government.
Case Study The Importance of Off-Label Compliance Training for Field-Based Operations — Effective Methods and Training Activities
In order to best protect from off-label compliance risks, it is essential for companies to first have an effective and efficient internal training program in place. With continually changing regulations, including the new guidance, it is important to check that your training practices are up to date and adhere to FDA and DOJ guidelines. Corporate training programs are the foundation for ensuring compliant interactions between field-based teams and prescribers, and where compliance teams can ensure that all team members are adequately trained and properly informed. Proper off-label compliance trainings help establish clear-cut lines between compliant and illegal activities, while defining what constitutes as off-label interactions during internal and external communications. Evolving technologies such as social media, smart phones, iPads only increase compliance risks as they increase the mobility of field-based teams, creating further need for compliance trainings.
Promotional Review Committee’s Role in Evolving Compliance Environment
In the current environment, is there value in having a member of the compliance department as a voting member of your promotional review committee? It’s been almost ten years since the Department of Health and Human Services published OIG Compliance Program Guidance for Pharmaceutical Manufacturers. In that time, the compliance function has become a more prominent part of company life. Is wide spread acceptance as full voting members on promotional review committees the next step?
The meeting promises to be educational and provide practical information for life science companies.